# K972445: Pulpdent OX-Out

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Oct 2, 1997 after 94 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ultradent DeOx: named in the summary without a submission number
- (no number) Panavia Oxyguard II: named in the summary without a submission number

## Indications for use
Pulpdent OX-OUT is a tinted, glycerine and polyethylene glycol based gel used to block oxygen from the surface of anaerobic setting, resin-type dental restorative materials. Pulpdent OX-OUT prevents the formation of an oxygen inhibited layer at the margins of a restoration. It also contains a polymerization accelerant to improve setting. Pulpdent OX-OUT is indicated during cementation of metal bridges, crowns and inlays/onlays, cementation of silanated porcelain and cured composite crowns or inlays/onlays, cementation of preformed or cast posts and cores, and for bonded amalgam restorations.

Source page: https://510kreport.com/device/K972445
Methodology: https://510kreport.com/methodology